The primary objective of the multi-center, open-label, non-randomized phase II trial is to evaluate tumor response (the level of anti-tumor activity of EOquin), with time to recurrence and overall safety as the secondary objectives.
Data previously reported from the phase II trial confirmed anti-tumor activity against refractory superficial bladder cancer, as evidenced by 61% of patients showing a complete response (complete disappearance of the tumor as confirmed by biopsy) after receiving six weekly treatments with EOquin.
Results also demonstrated that EOquin was well-tolerated, with no systemic toxicity, and local toxicity limited to chemical cystitis in one patient, dysuria and hematuria. While follow-up was short, no responding patient had relapsed, confirming the promising response duration observed in a previous phase I trial.
“We are pleased with the rapid enrollment of this trial,” stated Dr Rajesh Shrotriya, chairman, CEO and president of Spectrum Pharmaceuticals. “The treatment of refractory superficial bladder cancer represents a significant unmet medical need, and we look forward to advancing the potential of EOquin in patients with this disease.”
The company plans to present phase II data on EOquin at the European Association of Urologists Congress, which will be held in Turkey in March 2005.